TABLE 1.
Group |
n (%) in treatment groupa |
|||
---|---|---|---|---|
250 mg REL + IMI | 125 mg REL + IMI | Placebo + IMI | Total | |
Randomizedb | 118 | 116 | 117 | 351 |
Treated with any study therapy | 117 (99.2) | 114 (98.3) | 116 (99.1) | 347 (98.9) |
Completed study medication | 112 (94.9) | 107 (92.2) | 111 (94.9) | 330 (94.0) |
Discontinued study medication because of: | 5 (4.2) | 7 (6.0) | 5 (4.3) | 17 (4.8) |
Adverse event | 1 (0.8) | 4 (3.4) | 3 (2.6) | 8 (2.3) |
Death | 0 (0.0) | 1 (0.9) | 0 (0.0) | 1 (0.3) |
Lack of efficacy | 0 (0.0) | 0 (0.0) | 1 (0.9) | 1 (0.3) |
Lost to follow-up | 0 (0.0) | 0 (0.0) | 1 (0.9) | 1 (0.3) |
Physician decision | 0 (0.0) | 2 (1.7) | 0 (0.0) | 2 (0.6) |
Protocol violation | 2 (1.7) | 0 (0.0) | 0 (0.0) | 2 (0.6) |
Insufficient drug supply | 1 (0.8) | 0 (0.0) | 0 (0.0) | 1 (0.3) |
Withdrawal by subject | 1 (0.8) | 0 (0.0) | 0 (0.0) | 1 (0.3) |
Completed study | 114 (96.6) | 109 (94.0) | 114 (97.4) | 337 (96.0) |
Discontinued from study because of: | 4 (3.4) | 7 (6.0) | 3 (2.6) | 14 (4.0) |
Adverse event | 0 (0.0) | 2 (1.7) | 0 (0.0) | 2 (0.6) |
Death | 0 (0.0) | 1 (0.9) | 0 (0.0) | 1 (0.3) |
Lost to follow-up | 0 (0.0) | 1 (0.9) | 2 (1.7) | 3 (0.9) |
Progressive disease | 0 (0.0) | 1 (0.9) | 0 (0.0) | 1 (0.3) |
Protocol violation | 3 (2.5) | 1 (0.9) | 0 (0.0) | 4 (1.1) |
Insufficient drug supply | 1 (0.8) | 0 (0.0) | 0 (0.0) | 1 (0.3) |
Withdrawal by subject | 0 (0.0) | 1 (0.9) | 1 (0.9) | 2 (0.6) |
REL, relebactam; IMI, 500 mg imipenem-cilastatin.
Percentages are based on the number of subjects randomized as the denominator.